Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Aurimod GmbH
With
Klinikum Klagenfurt am Wörthersee
La Tour Hospital
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female aged 18 to 65 years at screening
Patient has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures
Chronic back pain with or without leg pain (CBLP) persisting for at least 3 months
A minimum of 70 (out of 180) points on the Computer User Self-Efficacy Scale at the screening visit
Patient is constant with respect to pain treatment during the screening phase
A daily average VAS \>= 4 on at least half of the days in the screening phase
Compliance with the daily status reporting requirements as demonstrated by having valid required data entries for all days. It is acceptable if data of one day is missing in the screening phase
You may not be if
Patients with age under 18
Hemophilia
Infection, eczema, or psoriasis at application site
Numbed and desensitized skin at the application site
Florid malignant diseases
Mental and physical impairments that represent a source of risk for handling the device
The presence of a cardiac pacemaker, defibrillator, cochlear implant, or other active implantable device
Vagal hypersensitivity
Indication for back surgery
High-grade spinal stenosis
Patients with other active implants
Patients with autonomic disorders
Patients with diabetes type I or II
Patients taking Beta-Blockers
Patients taking drugs carrying the potential risk of arrhythmia (tricyclic medications, Alzheimer drugs, etc.)
Clinically significant hip or knee arthritis
Allergy against rescue medication used during the study
History of Vagus Nerve Stimulation
Pregnant or nursing female patients
Patients with arrhythmia, bradycardia, other rhythm disorders or any other clinically significant cardiac anomalies detected during ECG at screening
